Trial Outcomes & Findings for A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease (NCT NCT01870388)
NCT ID: NCT01870388
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Predose up to 48 hours (h) postdose
Results posted on
2017-06-06
Participant Flow
An interim analysis was to be performed after ≤6 participants (pts) each in Group (G) 1 and G2 completed the study. If a \<1.3-fold difference in exposure was seen between pts with moderate hepatic impairment (G2) and pts with normal hepatic function (G1), then pts with mild hepatic impairment (G3) were not to be enrolled. No pt was enrolled in G3.
Participant milestones
| Measure |
Baricitinib (Healthy Participants)
Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
|
Baricitinib (Moderate Hepatic Impairment)
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Received 1 Dose of Study Drug
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
Baseline characteristics by cohort
| Measure |
Baricitinib (Healthy Participants)
n=8 Participants
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
|
Baricitinib (Moderate Hepatic Impairment)
n=8 Participants
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose up to 48 hours (h) postdosePopulation: Participants who received 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Baricitinib (Healthy Participants)
n=8 Participants
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
|
Baricitinib (Moderate Hepatic Impairment)
n=8 Participants
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)
|
35.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
38.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
PRIMARY outcome
Timeframe: Predose up to 48 h postdosePopulation: Participants who received 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Baricitinib (Healthy Participants)
n=8 Participants
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
|
Baricitinib (Moderate Hepatic Impairment)
n=8 Participants
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib
|
295 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 25
|
350 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
Adverse Events
Baricitinib (Healthy Participants)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Baricitinib (Moderate Hepatic Impairment)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baricitinib (Healthy Participants)
n=8 participants at risk
Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
|
Baricitinib (Moderate Hepatic Impairment)
n=8 participants at risk
Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60